Development and Validation of Reversed Phase High Performance Liquid Chromatographic Method for Simultaneous Estimation of Paracetamol, Caffeine and Carisoprodol in Tablet Formulation

Abstract

Combined dose tablet formulation containing Paracetamol, Caffeine and Carisoprodol is used for the
treatment of low back pain, post traumatic muscle spasm, sprains, strains and tenosynovitis. In this study
a simple, specific, precise and accurate reverse phase high performance liquid chromatographic (RPHPLC) methods has been developed for simultaneous estimation of paracetamol (PAR), caffeine (CAF)
and carisoprodol (CAR) in tablet dosage form. In the proposed chromatographic method separation was
achieved by HiQ silC-18HS column (250 mm× 4.6 mm), with mobile phase containing Acetonitrile:
Buffer (0.1mol L-1 Orthophosphoric Acid) (30:70 v/v) and the pH of the Buffer was adjusted to 3.1 by
triethylamine. The flow rate was 1.0 ml min-1
and effluent was monitored at 232.2 nm. The retention
time of CAF, PAR and CAR were 2.804 min, 4.815 min and 6.718 min respectively. The linearity for
PAR, CAF and CAR were in the range of 5-25 µg mL
-1
, 5-25 µg mL
-1
and 10-50 µg mL
-1
respectively.
The recoveries of PAR, CAF and CAR were found in the range of 99.05-99.78 %, 98.47-99.90 % and
98.92-99.56 % respectively. The proposed methods were validated as per International Conference on
Harmonisation (ICH) guidelines by means of different parameters likes linearity, precision, accuracy,
and limit of detection, limit of quantitation, range and selectivity, robustness ruggedness, solution
stability as per ICH guidelines and successfully applied to the estimation of PAR, CAF and CAR in the
tablet dosage form.